Senior Manager, Quality Control

Cellares

Cellares

Administration, Quality Assurance
South San Francisco, CA, USA
Posted on Wednesday, March 8, 2023
Position Summary
We are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our facility located in South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in Cell & Gene Therapy operations.
This is a multidisciplinary role & this individual will further interface across many parts of the company to support novel products used in the cell and gene therapy world. This role will be a hands-on resource reporting to the Director of Quality Control.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

  • Schedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samples
  • Ensure the quality control lab is held to GxP standards and safety standards
  • Create/Review and approve Certificate of Analysis
  • Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
  • Review and approve data to ensure accuracy and regulatory compliance
  • Collaborate with QC Microbiology management in establishing specifications and justification of specifications
  • Create/Review and approve new and revision of analytical test methods
  • Create/Review and approve method validation protocols/reports and other documentation such as analytical reports
  • Create/Review and approve stability protocols and reports
  • Create/Review and approve quality control operation procedures
  • Manage the validation of analytical methods used in QC as well as the transfer and validation of methods to contract testing laboratories
  • Manage training of other analysts to perform laboratory procedures and assays
  • Participate in internal assessments and audits as required
  • Manage stability program
  • Serve as Quality Control representative during cross-functional/project meetings
  • Serve as subject matter expert between Quality Control and other departments, vendors, or contractors
  • Behave as a working backup QC analyst for testing activities as needed
  • Support Quality Systems such as Change Control, Deviation, CAPA, Audits, Quality Metrics
  • Manage and grow a phase appropriate team of Quality Control personnel
  • Establish user requirements for purchase of new Cellares GMP lab equipment
  • Manage equipment validation, calibration, maintenance, and troubleshooting
  • Assemble and report contract laboratory testing data
  • Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
  • Other duties as assigned.

Requirements

  • BA or B.S. degree in a science discipline required, or comparable experience. M.S. in a scientific discipline is preferred
  • Minimum of 7 years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
  • At least 2 years in a managerial role
  • Prior experience related to method development/validation
  • Strong background in cell biology, immunology, and molecular biology
  • Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211.
  • Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
  • Identifying, authoring, and supporting OOS, DRs, and CAPAs
  • Equipment IQ/OQ/PQ experience
  • Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
  • Excellent interpersonal, verbal, written communication and organization skills
  • Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
  • Must be able to commute to South San Francisco
This is Cellares
Cellares is creating the future of cell therapy manufacturing. The company is developing an innovative cell therapy manufacturing solution that is robust, cost-effective and scalable so that cell therapies are more affordable and widely available to patients in need. Our multidisciplinary team comes together from diverse backgrounds with a shared passion for accelerating access to life-saving cell therapies. We value integrity, curiosity, the courage to grow and embrace change. At Cellares, you will collaborate with a world class team of engineers, scientists, and business leaders who are as excited about improving the world as you are.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.